Site Start Up Associate Senior or level II
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. We’re looking for an exceptional Site Start-Up Associate (Contractor) to bring your passion to our team.
This role will be focused on providing support for both Sweden & Denmark and we can consider candidates working home based from either location.
You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world. At Premier Research, we are science-minded and heart-centered. Join us.
- Takes responsibility for quality deliverables at the country level for site start-up.
- Follows project requirements and applicable country rules.
- Proactively forecasts submission/approval timelines and ensures they are adhered to.
- Local Clinical Trial Applications Specialist - may serve as the primary point of contact for the Project Manager, Clinical Lead and Regulatory Start-up Lead (or designee) during start-up on allocated projects.
- Prepares and submits Central EC Applications, Local EC Applications, RA Applications and other local regulatory authorities or hospital approval submissions as required.
- Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules.
- Submits end of study notifications to Regulatory Authorities, Ethics Committees and other local authorities.
- Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Local Investigator Contract and budget negotiator - produces site-specific contracts from country template. Submits proposed contract and budget for site.
- Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
- Prepares checklist for IP release.
- Ensures accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF.
- Provides all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up.
- Collects information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees.
- Provides country-level intelligence on site start-up.
- Ensures that local country regulatory intelligence is maintained on the central repository.
- Provides quality review of the informed consent and adapts the template as appropriate.
You'll need :
- 3+ years of related experience
- Thorough knowledge of ICH/GCP and/or ISO14155 and local regulatory authority drug research and development regulations required
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job
- Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site Start-Up activities will be carried out
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions
- You will be an excellent team player, collaborative and able to build an effective team
- You will have the ability to multitask and work effectively in a fast-paced environment with changing priorities
- You will be able to demonstrate strong verbal and written communication and negotiation skills
- You will have excellent organizational and time-management skills and be able to prioritize work to meet deadlines
What we offer:
This position is offered with a competitive hourly rate.